I have been asked to respond to a letter from Dr. Mahabir entitled “A Problem of Power” regarding “A Prospective, Randomized, Double-Blind, Controlled Trial of Continuous Local Anesthetic Infusion in Cosmetic Breast Augmentation,” which appeared in the March 2008 issue of the Journal (2008;121:711–715).
First, I would concede that my personal sophistication regarding statistical analysis is limited, and thus our research efforts routinely employ the assistance of our inhouse statisticians and medical research analysts to determine the appropriate statistical analysis and often to contribute to study design. I would also respond that we reported our results accurately, reflecting those data that we obtained. The problem with any piece of research producing inconclusive or negative results is that it is often looked upon by reviewers as less valuable than studies showing positive or definitive results. However, it is my observation that the majority of publications within the area of aesthetic surgery are lacking in scientific design and more often reflect clinical experience. Our intention was to pursue a study with each patient serving as her own control. As with any research, we were disappointed that our results were not more definitive, but we held no bias as to whether that result should have been positive or negative.
I would challenge some of the statements in Dr. Mahabir's letter, such as his question of methodology in criticizing the use of patients as their own controls. Pain is, of course, very subjective in nature and varies widely from patient to patient. Thus we remain firm that using the patients as their own controls when possible is the cleanest method for study. This removes the concept of one patient typically sensing a higher level of pain than a different patient might. Personal experience over many years of performing augmentations quite often has shown that patients have more or less pain on one side than the other, usually without any discernible reason. Our study did demonstrate that patients could identify which breast hurt more or less. Certainly, using the patient as her own control does make the study more cumbersome and relies on that patient's interpretation of her pain level in each breast. In essence, what we are trying to do in any study of this nature is to make objective comparison of a subjective phenomenon. This study analyzed one specific method of local anesthetic infusion in a specific amount. We would certainly not defend that this is the only or even the most effective method of utilizing local infusion methodology for pain control. Pain pumps have been shown to have benefit in other clinical situations and in the breast, but in our study we were unable to demonstrate an advantage.
The breast augmentation patient is typically healthy and, particularly when implants are placed submuscularly, has a definable period of fairly intense pain that must be alleviated in some appropriate manner, whether with narcotics or local infusion. In a design sense, we remain happy with our choice and accept the fact that we did not provide a more definitive answer to the question. However, I suspect that our patients given this protocol, device, and dosage level would likely not choose to incorporate the additional expense and awkwardness of having pain pumps were they to be faced with this choice in the future.
We have all had situations in which, after conducting the study, whether in the laboratory or clinically, we have wondered if we could have shown a difference if the sample size had been larger. But pursuing additional recruitment of subjects to prove a point is risky. In this situation, it is entirely possible that the results obtained (which were somewhat counterintuitive) might easily have persisted with even a larger sample size.
I compliment Dr. Mahabir's efforts to encourage us to a greater level of precision and foreplanning in research and for, I hope, making all of us think through and plan studies that can be more definitive.
C. Lin Puckett, M.D.
Division of Plastic Surgery
University of Missouri
One Hospital Drive
Columbia, Mo. 65212
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